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NCT01288495 · ClinicalTrials.gov registry record · NA
Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance
A NA study, sponsored by Augusta University.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01288495 is a NA study that was terminated before completion, run by Augusta University. The registered enrollment target is 15 participants.
The verdict
NCT01288495, a NA study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms. We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will decrease GI symptoms in subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose. Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a randomized, double blind, cross over study. Methods: We propose to investigate the effects of co-administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose intolerance, in a randomized, double blind, cross over study. Data Analysis: The primary outcome measure will be a comparison of baseline breath sample values and study visit breath sample values. Additionally, we will assess subject-reported occurence and severity of nine gastrointestinal symptoms during the test on a visual analog scale (VAS). Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve with ingestion of supplemental L-alanine (along with foods containing free fructose or high fructose content). We additionally expect treatment of DFI with administration of L-alanine powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for patients.
Interventions
- DIETARY_SUPPLEMENT Metamucil
- DIETARY_SUPPLEMENT supplemental L-alanine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288495
The ClinicalTrials.gov registry entry for NCT01288495 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metamucil is the first listed.
NCT01288495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288495 about?
NCT01288495 is a clinical study titled "Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance". Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms. We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will ...
What is the current status of trial NCT01288495?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2009-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01288495?
The interventions under investigation include: Metamucil (DIETARY_SUPPLEMENT), supplemental L-alanine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01288495?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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